Treatment of Plantar Keratosis With Medicinal Plant in Diabetic Patients
NCT ID: NCT03447925
Last Updated: 2020-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
90 participants
INTERVENTIONAL
2017-06-01
2020-01-01
Brief Summary
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Detailed Description
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The medicinal plant used in this study is a keratolytic agent, healing, emollient, bactericide and fungicide. The purpose of this study is evaluate the effectiveness of this medicinal plant in the treatment of keratosis in diabetic patients. This study will be controlled, randomized, comparative with standard drug and double-blind. Will be included in the study 90 adult diabetic patients type 1 or 2, with keratosis, both sexes, but do not show feet ulcerated lesions. Patients will be randomised controlled trials in three groups, with 30 people in each, which will receive topical treatment with medicinal plant (treatment group, TG), salicylate 10% (salicylate group, SG) and vaseline cream (control group, CG). The treatment will be once a day, for 30 consecutive days. Numerical scores will be made of the sites with keratosis and individual areas and global measures in the first, 30th days of treatment. The results obtained will be submitted to statistical comparison. This research will follow the standards set by resolution 466/12 of the National Health Council, the Vale do Sapucaí University, for research with human beings and will be conducted in accordance with the ethical recommendations of the Declaration of Helsinki.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Medicinal Plant X Salicylate
Treatment Group (TG) will receive topical treatment with medicinal plant and Salicylate Group (SG) will receive topical treatment with salicylate 10%, both once a day, for 30 consecutive days.
Medicinal Plant
Medicinal Plant Extract with vaseline cream
Salicylate
Salicylate 10% with vaseline cream
Medicinal Plant X Vaseline
Treatment Group (TG) will receive topical treatment with medicinal plant and Control Group (CG) will receive topical treatment with vaseline cream, both once a day, for 30 consecutive days.
Medicinal Plant
Medicinal Plant Extract with vaseline cream
Vaseline
Vaseline cream
Interventions
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Medicinal Plant
Medicinal Plant Extract with vaseline cream
Salicylate
Salicylate 10% with vaseline cream
Vaseline
Vaseline cream
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Universidade do Vale do Sapucai
OTHER
Responsible Party
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Beatriz Bertolaccini Martínez
Universidade do Vale do Sapucai
Locations
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Beatriz B Martinez
Pouso Alegre, Minas Gerais, Brazil
Countries
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References
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Arosi I, Hiner G, Rajbhandari S. Pathogenesis and Treatment of Callus in the Diabetic Foot. Curr Diabetes Rev. 2016;12(3):179-83. doi: 10.2174/1573399811666150609160219.
Caravaggi C, Sganzaroli A, Galenda P, Bassetti M, Ferraresi R, Gabrielli L. The management of the infected diabetic foot. Curr Diabetes Rev. 2013 Jan 1;9(1):7-24.
Other Identifiers
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65431417.4.0000.5102
Identifier Type: -
Identifier Source: org_study_id